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CTRI Number  CTRI/2024/07/070199 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the Shodana effect of Dhoopanakarma with Shreevasadi and Nimbapatradi Dhoopa in Dushtavrana with special reference to Non-healing ulcers.  
Scientific Title of Study   A Randomized Comparative Clinical trial to evaluate the Shodana effect of Dhoopanakarma with Shreevasadi and Nimbapatradi Dhoopa in Dushtavrana with special reference to Non-healing ulcers  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali V Almelkar 
Designation  PG Scholar 
Affiliation  BVVS Ayurved Medical and Hospital Bagalkot 
Address  Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  8050704538  
Fax    
Email  vaishalialmelkar805070@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh S Kulkarni 
Designation  Professor and HOD 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot 
Address  Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9886664541  
Fax    
Email  dryogesh6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M S Hiremath 
Designation  Professor and Incharge Principal  
Affiliation  BVVS Ayurved Medical College and Hospital  
Address  Department of Rachana Shareera BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9482631399  
Fax    
Email  malikdost4u@rediffmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College And Hospital Bagalkot Karnataka 587101 
 
Primary Sponsor  
Name  BVVS Ayurved Medical College and Hospital  
Address  BVVS Ayurved Medical College and Hospital Bagalkot 587101 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishali V Almelkar  BVVS Ayurved Medical College and Hospital Bagalkot 587101  Shalyatantra OPD Room No 03 BVVS Ayurved Medical College and Hospital Bagalkot 587101
Bagalkot
KARNATAKA 		 8050704538

vaishalialmelkar805070@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS Ayurveda Medical college and Hospital Bagalkot Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-vraNadhUpanam, व्रणधूपनम् (Procedure Reference: Bhavaprakasha, Procedure details: Dhoopana procedure is carried out for 15 minutes with Nimbapatradi dhoopa for 7days)
2Intervention ArmProcedure-vraNadhUpanam, व्रणधूपनम् (Procedure Reference: Chakradatta, Procedure details: Dhoopana procedure is carried out for 15 minutes with Sreevasadidhoopa for 7days)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  •Non -healing ulcers of lower limbs.
•Patients of age group between 18-70 years and irrespective of gender.
•Patient suffering from Dushtavrana having two or more classical symptoms.
•Patients of Non-healing ulcers with Controlled Diabetes Mellitus and Hypertension.
 
 
ExclusionCriteria 
Details  •Patients having Ulcer of Gangrenous, Syphilitic, Tuberculosis, Malignant, Marjolin and Bedsore.
•Patients suffering from RVD and HBsAg.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in
1.Discharge
2.Pain
3.Slough
4.Foul smell 		 7 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in size of the ulcer.
Growth of granulation tissue.  		 After 10 Days. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Vrana Chikitsa has been given importance in the classics in which Shashtiupakramas are mentioned by Acharya Sushruta.1 Dhoopanakarma is one among them in which drugs of herbal, herbo-mineral or animal origin is used for Vrana Dhoopana.

Acharya Sushruta explained Dushta Vrana Lakshanas as Krishna-Rakta-Peeta- Shukla Varna, Putimamsa, Puyasrava, Atyartavedana, Dushtashonitasrava, Daha, Paka, Raga, Kandu, Shopha and Deerghakaleena2. Dushtavrana can be correlated to non-healing ulcer in contemporary science by its characteristic features as pain, discharge, itching, burning sensation and foul smell3. Dhoopana is an integral part of Rakshavidhi which ensures the protection of vrana against the microbes and it act as Vranashodaka by reducing Vedana and Srava.4 

         A non-healing ulcer is a major health problem and it affects nearly 6 million populations worldwide. In India it is reported as 4.5 per 1000 population, the incidence of chronic ulcers is expected to increase as the population age increase5.

 Non-healing ulcers are treated by antibiotics, but long term usage of these will develop resistance. Hence we adopt Acharya Sushruta’s various Shodana measures like Sharirika Shodana by Vamana, Virechana and Stanika Shodana by Kashaya, Avachurana, and Dhoopana 6 etc.

 Acharya Chakradatta has mentioned about Shreevasadi Dhoopa under Vranashota Chikitsa for the Vrana Dhoopana which contains drugs like Shreevasa, Guggulu, Agaru, Shala niryasa which possess Krimigna and Vedanahara7 properties.

 Acharya Bhavamishra has mentioned about Nimbapatradi Dhoopa under Vranashotadikara for the Vrana Dhoopana which contains drugs like Nimbapatra, Vacha, Hingu, Sarpi, Lavana and Sarshapa8.      

Here an attempt is made to evaluate and compare the Shodana effect of Shreevasadi Dhoopa and Nimbapatradi Dhoopa in Dushtavrana with special reference to Non-healing ulcers.  

    

 

 
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